药品注册申请号:083590
申请类型:ANDA (仿制药申请)
申请人:RISING
申请人全名:RISING PHARMA HOLDINGS INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 NAPHAZOLINE HYDROCHLORIDE NAPHAZOLINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 0.1% No No None 1974/08/22 Approved Prior to Jan 1, 1982 Discontinued
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2012/11/30 SUPPL-23(补充) Approval Labeling STANDARD
2002/09/30 SUPPL-21(补充) Approval Manufacturing (CMC)
1999/08/25 SUPPL-19(补充) Approval Manufacturing (CMC)
1999/06/07 SUPPL-20(补充) Approval Manufacturing (CMC)
1996/08/08 SUPPL-18(补充) Approval Manufacturing (CMC)
1995/09/14 SUPPL-17(补充) Approval Manufacturing (CMC)
1995/09/14 SUPPL-16(补充) Approval Manufacturing (CMC)
1995/09/14 SUPPL-15(补充) Approval Manufacturing (CMC)
1995/09/14 SUPPL-14(补充) Approval Manufacturing (CMC)
1995/09/14 SUPPL-13(补充) Approval Manufacturing (CMC)
1995/09/14 SUPPL-12(补充) Approval Manufacturing (CMC)
1995/09/14 SUPPL-11(补充) Approval Labeling
1995/09/14 SUPPL-10(补充) Approval Manufacturing (CMC)
1995/09/14 SUPPL-9(补充) Approval Manufacturing (CMC)
1991/07/15 SUPPL-7(补充) Approval Labeling
1991/04/10 SUPPL-8(补充) Approval Labeling
1987/08/07 SUPPL-6(补充) Approval Manufacturing (CMC)
1987/01/15 SUPPL-5(补充) Approval Manufacturing (CMC)
1974/08/22 ORIG-1(原始申请) Approval
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
本品无治疗等效药品
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